As your program progresses, we ensure a seamless transition from discovery to development with chemistry, analytical, formulation, and regulatory capabilities that are designed for speed, compliance, and scalability.
Our capabilities include:
Process Chemistry & Route Scouting
Design of robust, scalable synthetic routes for NCEs and oligonucleotides, including challenging chemistries (e.g., chiral centers, unstable intermediates, multiple functional groups)
Development of conjugation strategies for peptides, ADCs, mRNA delivery vehicles, etc.
Process optimization under quality-by-design (QbD) frameworks
Analytical Method Development & Qualification
Development of stability-indicating assays (HPLC, LC-MS, GC, KF, etc.)
Physicochemical characterization of NBEs (e.g., aggregation, charge variants, potency assays)
Support for raw material and impurity profiling, genotoxic impurity analysis, residual solvents, polymorph screening, etc.
Preclinical Formulation & Stability
Formulation of NCEs, peptides, and oligonucleotides for repeat-dose tox studies (solution, suspension, lyophilized, liposomal, etc.)
Excipient compatibility, container closure selection, and accelerated stability studies
IND/IMPD-Enabling Supplies & Documentation
Non-GMP and tox-batch manufacturing of APIs and formulated drug product
Support for Module 3 preparation, including specifications, batch records, validation protocols, and stability summaries
Coordination of IND/IMPD data packages and Q&A support for pre-IND meetings
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